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FDA 510(k)

TD-7301 Spirometer (TD-7301)

K-Number: K241843 · 2024-11-20

ApplicantGostar Co., Ltd.
Decision Date2024-11-20
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TD-7301 Spirometer (TD-7301) is a medical device manufactured by Gostar Co., Ltd.. It received FDA 510(k) clearance on 2024-11-20 under approval number K241843. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TD-7301 Spirometer (TD-7301)?

TD-7301 Spirometer (TD-7301) is a medical device that received FDA 510(k) clearance on 2024-11-20. It is manufactured by Gostar Co., Ltd.. The 510(k) number is K241843.

When was TD-7301 Spirometer (TD-7301) approved by the FDA?

TD-7301 Spirometer (TD-7301) received FDA 510(k) clearance on 2024-11-20, under approval number K241843.

What company makes TD-7301 Spirometer (TD-7301)?

TD-7301 Spirometer (TD-7301) is manufactured by Gostar Co., Ltd..

What is the FDA product code for TD-7301 Spirometer (TD-7301)?

The FDA product code for TD-7301 Spirometer (TD-7301) is BZG.

Other Devices by Gostar Co., Ltd.

K222810TD-7301 Peak Flow meter K221419TD-5010 Lancing Device and TD-5084 Sterile Lancets

Related Devices (Code: BZG)

K161676Q13 SPIROLYSER®Fim Medical K160116SpiroScoutGanshorn Medizin Electronic GmbH K160253Vitalograph Model 6300 microVitalograph (Ireland) , Ltd. K150515IQSense Flow Sensor MouthpieceSdi Diagnostics, Inc. K163249GoSpiroMonitored Therapeutics, Inc. K161536EasyOne Air SpirometerNdd Medizintechnik AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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